PATENTS |
Janssen-Ortho Inc. v. Novopharm Ltd.
T-214-03
2004 FC 1631, Mosley J.
19/11/04
54 pp.
Application for order prohibiting Minister of Health (Minister) from issuing Notice of Compliance (NOC) to Novopharm Limited (respondent), regarding marketing of tablets of antimicrobial drug known generically as "levofloxacin" until after expiry of Daiichi's levofloxacin patent--Janssen licensed by Daiichi to sell drug in Canada under brand name "Levaquin"--Respondent alleging patent invalidity, non-infringement--Janssen "first person" referred to in Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), ss. 2, 4(1)--Pursuant to s. 6(1), "first person" initiates and seeks relief in this prohibition proceeding --Janssen listed patent at issue on Patent Register in relation to its notice of compliances (NOCs) for "Levaquin"--Markets drug in 250 mg, 500 mg tablet form--Respondent "second person" cited in ss. 2, 5(1)--By letter dated December 20, 2002, respondent sent notice of allegation (NOA) and now seeks notice of compliance to market 250 mg and 500 mg tablets of levofloxacin hemihydrate--Patent granted on June 23, 1992; filing date June 19, 1986, expiry date June 23, 2009--Daiichi also owner of patent for antibiotic "ofloxacin" --That patent expired--Burden of proof regarding patent validity--Legal burden of proving, on balance of probabi-lities, second person's allegations not justified on person seeking prohibition order, namely Janssen--Statutory presumption of validity--Simply rebutting presumption not meaning second person will be successful in prohibition application--Must still adduce sufficient evidence to challenge validity as well as applicant's expert evidence, while overall legal burden remaining with applicant--Patent purposively construed--Whether patent invalid because of obviousness--Test for obviousness set out in Beloit Canada Ltd. v. Valmet Oy (1986), 8 C.P.R. (3d) 289 (F.C.A.)-- Question to ask: whether solution taught by patent would be "plain as day" to skilled technician searching for something novel, without having to do experimentation or research-- Critical date for assessing obviousness claimed date of invention--In evaluating prior art on question of obviousness, such art must have been in public domain--080 patent described as "selection patent" in that levofloxacin selected out of its class of substances because of its beneficial properties--Respondent submits 080 patent does not meet requirements for selection patent--Janssen responding Patent Act, s. 32 permitting patent based on improvements to any patented invention and there was such inventive step in ascertaining levofloxacin possesses special properties in comparison to racemate, ofloxacin--In order to demonstrate sufficient inventive ingenuity, there must be shown some special advantage or quality, previously unknown, or advantage discovered for new use, which constitutes definite advance upon knowledge already existing with regard to original group or series--Improvements contemplated on already discovered racemic compound must demonstrate "sufficiently different" characteristics from what was already known in order for patent not to be declared invalid for obviousness--Review of prior art--Beneficial properties discovered, set out in 080 patent same as those found in ofloxacin, only to greater degree of effectiveness-- Respondent establishing on balance of probabilities technician skilled in art would have come directly and without difficulty to solution taught by 080 patent by simply conducting known, routine experiments with racemic ofloxacin--Claims in patent obvious--No inventive step involved--080 patent invalid for obviousness--Lack of novelty--Approach to anticipation found in Beloit--Three references as prior art in NOA with respect to anticipation and novelty--Test whether one piece of prior art teaches "discovery" claimed in patent; does single publication provide all information needed to produce claimed invention without exercise of any inventive skill; does prior publication contain such clear direction that person skilled in art, reading and following it, would in every case be led to claimed invention?--As none of references, considered separately, provide all information person of ordinary skill in art would require in order to be led to 080 patent, discovery novel--Janssen demonstrated allegation of invalidity on this ground not justified--Patent also not ambiguous--Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2 "first person", "second person" (as am. by SOR/99-379, s. 1), 4(1) (as am. by SOR/98-166, s. 3), 5(1) (as am. by SOR/99-379, s. 2), 6(1) (as am. by SOR/98-166, s. 5)--Patent Act, R.S.C., 1985, c. P-4, s. 32.